Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR
FDA 510(k) K031578 · Micrus Corp.
510(k) numberK031578
Submission
- Device name
- Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR
- Applicant
- Micrus Corp.
Sunnyvale, CA, US - Received
- May 20, 2003
- Decision date
- August 1, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 05/20/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | Balt USA, LLC | 01/27/2026SE |
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| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | Balt USA, LLC | 09/26/2025SE |
| K242154 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
| K242243 | Target Detachable CoilsHCG · Special | Stryker Neurovscular | 08/29/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K033813 | Micrus Modified Microcoil System, CerecyteHCG · Traditional | 02/04/2004SE |
| K032872 | Micrus Microcoil SystemHCG · Traditional | 11/28/2003SE |
| K032624 | Micrus MicrocatheterDQO · Traditional | 09/10/2003SE |
| K022420 | Micrus Stretch-Resistant Microcoil System, MSR01HCG · Traditional | 10/22/2002SE |
| K002056 | Micrus Microcoil Delivery System, MDS03HCG · Traditional | 01/11/2001SE |
Questions and answers
When was Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR cleared by the FDA?
Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR (K031578) received a 510(k) decision of Substantially Equivalent on August 1, 2003, 73 days after the submission was received.
What is the product code of K031578?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.